NEW DELHI – Artificial intelligence (AI) is increasingly gaining a foothold in India's health care landscape, with investors pouring money into the new technology, companies developing products and regulators looking to come up with much-needed rules.

India's Ministry of Health has reached out to the public for consultation on its national digital health blueprint that seeks to propel digital health care, including the use of AI in the biotech and medical technology sectors.

Analysts are pointing to the enormous potential of AI in health care and the need to put in place a full-fledged regulatory system for its use.

In July, the government released a blueprint for the development of such a system followed by a public consultation on Aug. 6, where participants sought clarification on how AI could help and be implemented in digital health.

In June 2018, the National Institution for Transforming India (NITI Aayog) released a discussion paper for a national strategy on AI. It purports the use of AI in health care can help address high barriers to access to health care facilities, particularly in rural areas that suffer from poor connectivity and a limited supply of health care professionals. This could be achieved with AI-driven diagnostics, personalized treatment, early identification of potential pandemics, imaging diagnostics and other applications.

Indian pharma companies have started to use data analytics and AI in drug discovery and development, but these efforts are still ad-hoc and experimental.

AI is not only attracting investors and innovators but may also create an opportunity to address some long-standing challenges to health care in India. AI solutions can augment scarce personnel and lab facilities, help with early detection, diagnostics, decision-making and treatment in large parts of India. For example:

• AI can be used in diabetic retinopathy. NITI Aayog is working with Microsoft and Bangalore-based Forus Health Pvt. Ltd to roll out a technology for early detection. 3Nethra is a portable device that can screen for common eye problems and integrates AI capabilities using Microsoft's retinal imaging APIs, making it possible to determine whether retinas are working. The technology can also solve quality issues with image capture and systems checks in place to evaluate the usability of the image captured.

• A report by EY, released at the opening of the annual BioAsia pharma conference in February in Hyderabad, stated some Indian companies are making headway in using digital technology to achieve operational efficiencies in research and development, manufacturing, supply chain and marketing. Digital technologies and data can, for example, improve R&D efficiency by helping with clinical data management or in supply chain management by using software to better tie supplies to demand.

• Indians are also working to put in place digitized batch production and quality analysis records for efficient manufacturing and quality assessments, as well as using AI to write standard operating procedures.

Could rules stifle innovation?

"Today, AI in health care is largely unregulated in India," said Pushpa Vijayaraghavan, director of Hyderabad-based Sathguru Management Consultants. There is active engagement from several start-ups pursuing AI-based products across a wide range of applications – image analysis in radiology and pathology, predictive or prognostic testing for cancer, predicting risk of contracting certain disease conditions such as neonatal sepsis and refractive error progression, she said.

PwC points to several challenges for AI in Indian health care, such as the absence of a health care regulatory body, unaffordability and unavailability of relevant data.

And a 2019 report of the Centre for Internet Society (CIS) in Bangalore cautions in an overview of AI in health care in India that "at present there is no regulatory oversight in this area, and there are fears that over-regulation could lead to a stifling of innovation. This calls for a national-level regulatory agency that oversees developments in AI in addition to formulating a framework that ensures transparency and accountability of AI systems while promoting and enabling innovation."

The CIS report also mentions the challenge of developing an appropriate certification mechanism.

"One of the biggest issues with the adoption of AI in health care in India is acceptability of results, which include direct results arrived at using AI technologies as well as opinions provided by medical practitioners that are influenced or aided by AI technologies," according to the report.

India also lacks a formal regulatory regime around data anonymization, which has given companies more flexibility and made it easier for start-ups to self-regulate. But, "the lack of regulation around data can be a double-edged sword, as on the one hand, it is easier for start-ups to collect data, however the regulatory vacuum causes uncertainty about what future changes might be in store."

Start-ups lead the way

In India, it is mostly start-ups that have begun to experiment with using AI in clinical trial procedures and other aspects of health care such as maintaining patient records.

Still, Indian startups face difficulty in getting approvals for clinical trials and there is lack of clear regulation.

"They are often frustrated about the delayed process for approvals for the use of AI, which often results in obsolescence of the technology by the time it is approved in the context of AI," according to the CIS report.

India could take cues from the U.S., where most of the AI applications are currently regulated as medical devices, with the FDA now spelling out specific guidance on software as a medical device.

"The ideal way forward for India would be for these applications to be covered under the current Medical Device Rules and to be brought under the ambit of regulatory oversight. This is particularly relevant in the case of some applications that have a greater bearing on clinical course of action," said Vijayaraghavan.